# K221955: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20

- Pathway: 510(k) (Traditional)
- Applicant: Realcloud Imaging Inc. Dba Realcloud Imaging
- Decided: Aug 31, 2022 after 57 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933455 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202664: Clio Prime and Clio Pedo, Sota Precision Optics, Inc. Dba Sota Imaging (2020) Summary page 5.

## Most influential descendants
- K241649: DUO1 and DUO2 (2024), 0 descendants of its own

## Indications for use
Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.

Source page: https://510kreport.com/device/K221955
Methodology: https://510kreport.com/methodology